Cambridge, UK – November 27, 2019 – Directed Systems Ltd today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of Hypotension Decision Assist (HDA)TM, a clinical decision support Software as a Medical Device (SaMD) that is installed upon a medically-rated touch-screen computer.

HDA is indicated to acquire, process and display arterial pressure and other key cardiovascular characteristics of adult patients who are at least eighteen years of age that are undergoing surgery where their arterial pressure is being continuously monitored by a vital-signs monitor. It is indicated for use to assist anesthesia healthcare professionals manage the blood pressure, hemodynamic stability and the cardiovascular system during such surgery.

“We are delighted to receive FDA 510(k) clearance for Hypotension Decision Assist (HDA)TM which marks a true milestone for Directed Systems as a business. Not only does this allow us to now begin marketing and sales in the United States, but it is tremendous validation of our Product Development to date.” Mark Leaning, CEO & Founder